Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis
1 other identifier
interventional
105
1 country
1
Brief Summary
The purpose of this research is to compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). Physical therapists commonly use conventional physical therapy techniques and dry needling to treat knee OA, and this study is attempting to find out if the addition of dry needling to conventional physical therapy has an equal, greater, or lesser effect than conventional physical therapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Feb 2015
Typical duration for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2017
CompletedMay 23, 2017
May 1, 2017
2.3 years
February 10, 2015
May 22, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
Change in Knee Pain Intensity (NPRS)
Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Pain)
5 Questions each worth 0-4 points with a maximum score of 20 points possible
Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Stiffness)
2 Questions each worth 0-4 points with a maximum score of 8 points possible
Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Physical Function)
17 Questions each worth 0-4 points with a maximum score of 68 points possible
Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Total)
24 Questions each worth 0-4 points with a maximum score of 96 points possible
Baseline, 2 Weeks, 6 Weeks, 3 Months
Secondary Outcomes (2)
Change in Global Rating of Change Score (GROC)
2 Weeks, 6 Weeks, 3 Months
Change in Medicine Intake (Frequency of medication intake)
Baseline, 3 months
Study Arms (2)
Dry Needling, Conventional PT
EXPERIMENTALConventional PT
ACTIVE COMPARATORInterventions
Dry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total)
Conventional physical therapy to include knee stretching, range of motion, and strengthening exercises,1-2 treatments per week X6 weeks (up to 10 sessions total)
Eligibility Criteria
You may qualify if:
- Report of knee pain of at least 2/10 per NPRS (0---10 scale) for \>3 months
- Report of at least 3 of the following per Altman et al. (1986)
- Over 50 Years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of synovium
You may not qualify if:
- Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- History of previous surgery to the knee
- History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
- History of a surgical procedure on either lower extremity in last 6 months
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Weakness involving a major muscle group of the lower extremity.
- Diminished patella or achilles tendon reflex
- Diminished or absent sensation to pinprick in lower extremity dermatome
- Involvement in litigation or worker's compensation regarding knee pain.
- Any condition that might contraindicate the use of electro-needling
- The patient is pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alabama Physical Therapy & Acupuncture
Montgomery, Alabama, 36117, United States
Related Publications (1)
Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.
PMID: 29864043DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Dunning, DPT FAAOMPT
American Academy of Manipulative Therapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DPT MSc FAAOMPT
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 27, 2015
Study Start
February 1, 2015
Primary Completion
May 19, 2017
Study Completion
May 19, 2017
Last Updated
May 23, 2017
Record last verified: 2017-05